BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3131662 · Received May 29, 2013

    Report

    Report Number
    2024168-2013-03335
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 4, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DISSECTION, AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE DISTAL RIGHT CORONARY ARTERY WITH MODERATE TORTUOSITY AND HEAVY CALCIFICATION. PRE-DILATATION WAS PERFORMED AND THE 2.5 X 18 MM XIENCE V STENT WAS DEPLOYED AT 12 ATMOSPHERES (ATM); HOWEVER, AS THE STENT DELIVERY SYSTEM BALLOON WAS BEING DEFLATED, A PROXIMAL EDGE DISSECTION WAS OBSERVED. A XIENCE PRIME STENT WAS USED TO TREAT THE DISSECTION SUCCESSFULLY. THE PATIENT HAD A GOOD RESULT WITH TIMI III FLOW AND NO RESIDUAL STENOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235974 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2100141

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention